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Lioresal Intrathecal is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of Lioresal Intrathecal via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Lioresal Intrathecal (baclofen injection) is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of Lioresal Intrathecal into the intrathecal space.

Spasticity of Spinal Cord Origin:

Evidence supporting the efficacy of Lioresal Intrathecal was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of Lioresal Intrathecal to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. Lioresal Intrathecal was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.

Spasticity of Cerebral Origin:

The efficacy of Lioresal Intrathecal was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross- over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; Lioresal Intrathecal was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross- over study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (p=0.066) and provided directionally favorable results. The last study, however, did not provide data that could be reliably analyzed.

Lioresal Intrathecal therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of Lioresal Intrathecal, patients must show a response to Lioresal Intrathecal in a screening trial.

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